对１４批静注丙球保留样品进行３年效期内稳定性观察结果表明：出厂后３年内制品的物理检查和热稳定性试验均合格，ｐＨ值没有变化，ＩｇＧ分子仍以单体形式存在，抗补体活性（ＡＣＡ）和ＰＫＡ含量未见升高，白喉抗毒素效价未见下降。表明我所大规模生产的静注丙球质量是稳定可靠的 14 batches of intravenous infusion of ball retention samples for 3-year validity of the observation results show that: after 3 years of factory product physical examination and thermal stability tests were qualified, the pH value has not changed, IgG molecules still exist as monomers , Anti-complement activity (ACA) and PKA content did not increase, diphtheria anti-toxin titer did not decline. It shows that the quality of static ball in our large-scale production is stable and reliable